Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-40...
FDA Recall #Z-1060-2015 — Class II — December 23, 2014
Product Description
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Reason for Recall
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.
Recalling Firm
Shape Medical Systems, Inc — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
564 devices
Distribution
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Code Information
Lot Numbers: 1412001, 1412002, 1412003 and 1412004
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated